Drug product
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).
D-0544-2026
Product summary
- Event
- Event 98870
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,880 bottles
- Official record key
drug-enforcement:D-0544-2026
Official wording
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Code information: Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Distribution pattern: Nationwide within the U.S
Derived failure modes
-
Manufacturing or process control
CGMP Deviations